233 results
Keyword Octreotide Remove keyword
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Orphan designation: Octreotide acetate for: Treatment of acromegaly
Date of designation: 05/08/2013, Positive, Last updated: 21/02/2022Octreotide acetate … opinion on orphan designation Octreotide acetate (oral use) for treatment … Ltd, United Kingdom, for octreotide acetate (oral use) for treatment … -
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Human medicine European public assessment report (EPAR): Mycapssa
Octreotide acetate, Acromegaly
Date of authorisation: 02/12/2022,
, Authorised, Last updated: 22/12/2022
Authorised octreotide Overview Mycapssa is a medicine … medicine. active substance octreotide. How is Mycapssa used? Mycapssa … active substance in Mycapssa, octreotide, is a somatostatin analogue … -
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Orphan designation: pasireotide for: Treatment of acromegaly
Date of designation: 08/10/2009, Positive, Last updated: 13/05/2020of growth hormone) such as octreotide and lanreotide, and pegvisomant … respond to treatment with octreotide. These assumptions will need … of growth hormone) such as octreotide and lanreotide, and pegvisomant … -
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Orphan designation: Octreotide chloride for: Treatment of acromegaly
Date of designation: 12/06/2009, Positive, Last updated: 30/05/2018Octreotide chloride … opinion on orphan designation Octreotide chloride (lipid depot solution … opinion on orphan designation Octreotide chloride (lipid depot solution … -
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Orphan designation: Octreotide acetate for: Treatment of idiopathic intracranial hypertension
Date of designation: 10/12/2021, Positive, Last updated: 05/05/2022Octreotide acetate … Octreotide acetate … -
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Orphan designation: Octreotide acetate for: Treatment of carcinoid syndrome
Date of designation: 13/01/2023, Positive, Last updated: 23/03/2023Octreotide acetate Overview This medicine … including flushing and diarrhoea. Octreotide acetate is a synthetic substance … 12 2.1.9. octreotide acetate - EMA/OD/0000095228 … -
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Octreotide acetate product-specific bioequivalence guidance
Last updated: 08/02/2019Octreotide acetate product-specific … Octreotide acetate product-specific … Octreotide acetate depot powder and …
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Human medicine European public assessment report (EPAR): Lutathera
lutetium (177Lu) oxodotreotide, Neuroendocrine Tumors
Date of authorisation: 26/09/2017,, Revision: 9, Authorised, Last updated: 13/02/2023
for patients treated with octreotide, a medicine already approved … for patients treated with octreotide, a medicine already approved … -
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Referral: Sandostatin LAR and associated names
ocreotide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 26/06/2014, EC decision date: 26/06/2014, Last updated: 27/06/2014contains the active substance octreotide. Octreotide is a synthetic substance … somatostatin. Like somatostatin, octreotide blocks the release of hormones … hormones. In Sandostatin LAR, octreotide is contained into microspheres … -
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Referral: Sandostatin and associated names
ocreotide, Article 30 referrals
Status: European Commission final decision, opinion/position date: 26/06/2014, EC decision date: 26/06/2014, Last updated: 27/06/2014contains the active substance octreotide. Octreotide is a synthetic substance … somatostatin. Like somatostatin, octreotide blocks the release of hormones … Sandostatin and associated names (octreotide, 0.05 mg/1 ml, 0.1 mg/1 ml … -
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Human medicine European public assessment report (EPAR): Signifor
pasireotide, Acromegaly; Pituitary ACTH Hypersecretion
Date of authorisation: 24/04/2012,, Revision: 14, Authorised, Last updated: 09/08/2022
19% of patients receiving octreotide, another somatostatin analogue … the somatostatin analogues octreotide or lanreotide. Continuation … 19% of patients receiving octreotide, another somatostatin analogue … -
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National expert: Karl Mikael Kälkner, Medical Products Agency (updated)
- Declaration of interests - 39.43 KB | PDF
- Curriculum Vitae - 33.58 KB | PDF
111In]_labeled DTPA_D_[Phe1]_octreotide scintigraphy. Cancer Res … Westlin JE. [111In_DTPA_D_Phe1]_octreotide scintigraphy in patients … predict therapy outcome with octreotide treatment: a pilot study … -
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Orphan designation: Lutetium (177Lu) edotreotide for: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 04/06/2014, Positive, Last updated: 05/09/2017treating GEP-NETs, including octreotide, everolimus, and sunitinib … treating GEP-NETs, including octreotide, everolimus, and sunitinib … -
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Orphan designation: Cyclo(-gamma-aminobutyryl-L-phenylalanyl-L-tryptophanyl-D-tryptophanyl-L-lysyl-L-threonyl-L phenylalanyl-N-3-carboxypropyl)-glycine amide, acetate salt for: Treatment of acromegaly
Date of designation: 06/12/2012, Positive, Last updated: 09/02/2016of growth hormone) such as octreotide and lanreotide, as well as … responses in adenoma cells than octreotide and a potentially better … growth hormone) such as octreotide and lanreotide, as well as … -
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National expert: Wouter de Herder, European Medicines Agency (updated)
- Declaration of interests - 42.42 KB | PDF
- Curriculum Vitae - 136.01 KB | PDF
1992) Het insulinoom en octreotide. Ned Tijdschr Geneeskd 136 … Reubi JC, Krenning EP (1993) Octreotide and Related Somatostatin … -
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National expert: Salvatore Piano, European Medicines Agency (updated)
- Declaration of interests - 42.38 KB | PDF
- Curriculum Vitae - 29.13 KB | PDF
albumin versus midodrine, octreotide and albumin in the treatment … -
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Orphan designation: (R)-1-[1-(4-acetoxy-3,3-dimethyl-2-oxo-butyl)-2-oxo-5-(pyridin-2-yl)-2,3-dihydro-1H-benzo[e][1,4]diazepin-3-yl]-3-(3-methylamino-phenyl)-urea (ceclazepide) for: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 14/12/2015, Withdrawn, Last updated: 04/04/2023treating GEP-NETs, including octreotide and lanreotide for the management … treating GEP-NETs, including octreotide and lanreotide for the management … -
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National expert: Jeroen Dekervel, Federal Agency for Medicines and Health Products (updated)
- Declaration of interests - 42.38 KB | PDF
- Curriculum Vitae - 33.31 KB | PDF
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Orphan designation: Recombinant human monoclonal antibody to insulin receptor for: Treatment of congenital hyperinsulinism
Date of designation: 14/07/2016, Positive, Last updated: 30/06/2022Products such as diazoxide and octreotide were used to reduce insulin … Products such as diazoxide and octreotide were used to reduce insulin … -
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Orphan designation: Lutetium-177(3+), S2,S7-cyclo[N-{4,7,10-tricarboxymethyl-1,4,7,10-tetraaza-cyclododecan-1-yl-acetyl}-4-chloro-L-phenylalanyl-D-cysteinyl-4-[(4S)-2,6-dioxo-1,3-diazinane-4-carboxamido]-L-phenylalanyl-4-(carbamoylamino)-D-phenylalanyl-L-lysyl-L-threonyl-L-cysteinyl-D-tyrosinamide]- for: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 20/09/2016, Positive, Last updated: 09/02/2022including everolimus, lanreotide, octreotide and sunitinib. Surgery was … including everolimus, lanreotide, octreotide and sunitinib. Surgery was … -
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Orphan designation: Fosbretabulin tromethamine for: Treatment of gastro-entero-pancreatic neuroendocrine tumours
Date of designation: 21/03/2016, Withdrawn, Last updated: 02/09/2021including lanreotide and octreotide for the management of symptoms … including lanreotide and octreotide for the management of symptoms … -
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Orphan designation: Glucagon analogue linked to a human immunoglobulin Fc fragment for: Treatment of congenital hyperinsulinism
Date of designation: 25/05/2018, Positive, Last updated: 23/05/2019Products such as diazoxide and octreotide were used to reduce insulin … Products such as diazoxide and octreotide were used to reduce insulin … -
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Orphan designation: Recombinant protein consisting of modified human growth hormone releasing hormone and the translocation and endopeptidase domains of botulinum toxin serotype D for: Treatment of acromegaly
Date of designation: 11/01/2012, Withdrawn, Last updated: 23/05/2019of growth hormone) such as octreotide and lanreotide, and pegvisomant … -
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Orphan designation: Glucagon for: Treatment of congenital hyperinsulinism
Date of designation: 08/10/2009, Positive, Last updated: 25/01/2019Medicines such as diazoxide and octreotide were used to reduce insulin … Medicines such as diazoxide and octreotide were used to reduce insulin … -
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Orphan designation: Glucagon for: Treatment of noninsulinoma pancreatogenous hypoglycaemia syndrome
Date of designation: 19/11/2018, Positive, Last updated: 18/03/2019Products such as diazoxide and octreotide were used to reduce insulin …